Solid state forms of elafibranor

Abstract

Disclosed are solid state forms of Elafibranor and salts thereof, processes for preparation thereof and pharmaceutical compositions thereof.

1 . A crystalline Elafibranor having a PXRD pattern having peaks at 7.8, 12.3, 13.5, 15.9 and 22.7 degrees 2-theta±0.2 degrees 2-theta. 
     
     
         2 . Crystalline Elafibranor according to  claim 1  having one, two, three or four additional peaks at 15.7, 16.3, 17.1, and 23.4 degrees 2-theta±0.2 degrees 2-theta. 
     
     
         3 . Crystalline Elafibranor according to  claim 1 , which is an anhydrous form. 
     
     
         4 . Crystalline Elafibranor according to  claim 1 , which is substantially free of any other solid state form of Elafibranor. 
     
     
         5 . Crystalline Elafibranor according to  claim 1 , which is non-hygroscopic. 
     
     
         6 . Crystalline Elafibranor according to  claim 1 , wherein the crystalline form shows less than 0.1% (w/w) of water absorption after exposure to 25° C./80% RH for 24 hours. 
     
     
         7 .- 9 . (canceled) 
     
     
         10 . A pharmaceutical composition or formulation comprising crystalline Elafibranor according to  claim 1 . 
     
     
         11 . A pharmaceutical composition or formulation according to  claim 10  comprising at least one pharmaceutically acceptable excipient, and wherein the pharmaceutical composition or formulation is for oral administration. 
     
     
         12 . A process for preparing a pharmaceutical composition or formulation according to  claim 10 , comprising combining crystalline Elafibranor and at least one pharmaceutically acceptable excipient. 
     
     
         13 . A process for preparing a different solid state form of Elafibranor comprising preparing crystalline Elafibranor according to  claim 1  and converting it to the different solid state form of Elafibranor. 
     
     
         14 . A method of treating nonalcoholic steatohepatitis,
 comprising administering a therapeutically effective amount of the crystalline Elafibranor according to  claim 1  to a subject suffering from nonalcoholic steatohepatitis, or otherwise in need of the treatment.   
     
     
         15 . A method of treating nonalcoholic steatohepatitis, comprising administering the pharmaceutical composition or formulation of  claim 10  to a subject suffering from nonalcoholic steatohepatitis, or otherwise in need of the treatment. 
     
     
         16 . A pharmaceutical composition or formulation according to  claim 10  comprising at least one pharmaceutically acceptable excipient, and wherein the pharmaceutical composition or formulation is in the form of a tablet or capsule.